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Recruiting NCT05888987

NCT05888987 Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

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Clinical Trial Summary
NCT ID NCT05888987
Status Recruiting
Phase
Sponsor CHU de Reims
Condition Infectious Keratitis
Study Type OBSERVATIONAL
Enrollment 46 participants
Start Date 2023-07-07
Primary Completion 2027-01-07

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
PCR multiplex by FilmArray

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 46 participants in total. It began in 2023-07-07 with a primary completion date of 2027-01-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy. Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea. The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.

Eligibility Criteria

Inclusion criteria: * Over 18 years old * With social security affiliation * Willing to participate this study * Hospitalized in our department for severe infectious keratitis Non-inclusion criteria: * Any prior (48 hours) or concomitant treatment with local or systemic antibiotherapy at time of corneal scrapping and swabbing * Patient not covered by the French Health Insurance * Unable to give informed consent

Contact & Investigator

Central Contact

Alexandre DENOYER

✉ adenoyer@chu-reims.fr

📞 03 26 78 78 88

Frequently Asked Questions

Who can join the NCT05888987 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Infectious Keratitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05888987 currently recruiting?

Yes, NCT05888987 is actively recruiting participants. Contact the research team at adenoyer@chu-reims.fr for enrollment information.

Where is the NCT05888987 trial being conducted?

This trial is being conducted at Reims, France.

Who is sponsoring the NCT05888987 clinical trial?

NCT05888987 is sponsored by CHU de Reims. The trial plans to enroll 46 participants.

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